Medical Device Risk Analysis: Risk Matrix (ISO 14971)
Dr. Oliver Eidel
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ISO 14971: Medical Device Risk Management
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Updated November 26, 2025
We've performed a simple risk analysis in our Google Sheet, but now we have to make everything a bit more structured, and creating a risk matrix is the next step! This will enable us to define which combination of probabilities and severities are acceptable.
00:00 Introduction
01:07 Simple risk table recap
02:05 Numerical probabilities
04:33 Defining medical harm in severities
05:33 Simple risk matrix
09:20 A better risk matrix
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
00:00 Introduction
01:07 Simple risk table recap
02:05 Numerical probabilities
04:33 Defining medical harm in severities
05:33 Simple risk matrix
09:20 A better risk matrix
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
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Dr. Oliver Eidel
I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
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